RecruitingPhase 1Phase 2NCT03882840

Induced-T Cell Like NK Cellular Immunotherapy for Cancer Lack of MHC-I

Induced-T Cell Like NK Cellular Immunotherapy for Cancers That Are Lack of MHC-I Expression


Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Enrollment

60 participants

Start Date

Jan 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

T effector cells and NK cells have mutual compensatory killing functions on various of cancer types. For those cancers that have no available targets for CAR-T cell generations, we established potent T cell-like NK cells (ITNK) with a specific conversion protocol for the T cells from the patient, to perform anti-cancer therapy, especially for those cancers that are lack of MHC-I molecule expression. We have finished pre-clinical investigations for the ITNK or CAR-ITNK cell therapy and scheduled to start a clinical phase I study.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Patients with advanced cancer, which express low or no MHC-I.
  • Life expectancy >12 weeks
  • Adequate heart,lung,liver,kidney function
  • Available autologous T cells
  • Informed consent explained to, understood by and signed by patient/guardian. 6. Patient/guardian given copy of informed consent.

Exclusion Criteria9

  • Had accepted gene therapy before;
  • Severe virus infection such as HBV,HCV,HIV,et al
  • Known HIV positivity
  • History of liver or other organ transplantation
  • Active infectious disease related to bacteria, virus,fungi,et al
  • Other severe diseases that the investigators consider not appropriate;
  • Pregnant or lactating women
  • Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day)
  • Other conditions that the investigators consider not appropriate.

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Interventions

BIOLOGICALITNK cell therapy

Infusion of ITNK/CAR-ITNK cells


Locations(1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

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NCT03882840